Biofeedback in Pediatric Inflammatory Bowel Disease

Ross Maltz

Status: Withdrawn

Conditions: IBD

Treatments: Behavioral: Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04269720

IRB18-01100

Details and patient eligibility

About

This prospective, randomized, longitudinal, controlled project will occur in two phases. Phase 1 is the pre-diagnosis data collection for treatment-naïve participants who are referred for a diagnostic endoscopy/colonoscopy due to suspicion of IBD. Phase 2 (RCT) is only for patients who are diagnosed with IBD. These patients will be randomized to receive biofeedback intervention daily for 8 weeks or no biofeedback intervention. All participants will receive physician directed standard of care treatment.

Full description

The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.

Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The inclusion criteria for Phase 1 are:

1. Age 8-17 years
2. Referred for a diagnostic colonoscopy with strong clinical concern for IBD
3. Live within a 2 hour drive of NCH

There is one additional inclusion criterion for Phase 2:

1. Patients have been diagnosed with IBD

Exclusion criteria

1. Participants are excluded if they have a comorbid chronic illness, perianal disease, current corticosteroid treatment, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.
2. Age and language are limited by the demands of the study (questionnaire completion)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

No Intervention group

Description:

Participants will not receive biofeedback intervention.

Biofeedback

Experimental group

Description:

Participants will receive a biofeedback intervention daily for 8 weeks. Each biofeedback session lasts approximately 10 minutes.

Treatment:

Behavioral: Biofeedback